Pangaea Express: PMPRB releases a statement, April 22, 2022

April 25, 2022

By Marla WeingartenSuzanne Solman

The PMPRB has responded to the statement made April 14, 2022, by the Federal Minister of Health, Minister Duclos regarding the Coming-into-Force of the Regulations Amending the Patented Medicines Regulations. The PMPRB will need to update the Guidelines based on these Regulations that move forward with the implementation of the new basket of comparator countries but not the new price regulatory factors, nor the requirements to file information net of all price adjustments.

The Board has stated that it will not be possible to finalize Guidelines by July 1, 2022. They will hold an expedited written consultation on what price tests should apply during this temporary period when neither the old nor the new guidelines are in effect. Thus, once the Regulations are published in the Canada Gazette, the Board will issue draft guidance on the provisional price tests to apply during this interim period.

Pangaea will continue to provide information on the Regulations and the draft guidance from the PMPRB.

For more information, please contact Suzanne Solman or Marla Weingarten.